Fungal Infection by SiteNCT07802600
Clinical, Dermoscopic, and Mycological Characteristics of Tinea Capitis in Children
An observational study of Fungal Infection by Site and Tinea Capitis, run by Sohag University at 1 site in Egypt.
Trial summary
Tinea capitis is a common dermatophyte infection of the scalp in children aged 0-9 years .The prevalence of tinea capitis in Egypt is 0.4% and higher in public than private schools, Boys were more affected than girls according to children by 5:1 ratio , It is more prevalent in those who live in urban areas, large… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Fungal Infection by Site, Tinea Capitis
- What is being tested?
- Dermoscopic examination: the findings are divided into pathognomic and non-specific signs, Direct Microscopy (KOH) examination and Fungal culture:
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2026to 20 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will be conducted at the Dermatology Outpatient Clinic in Sohag University Hospitals. Study population: The study population will be all patients with tinea capitis both male and female in childhood period, Aged 1-18 years old
Who may be able to join
- Both male and female in childhood period (1-18 years) with tinea capitis
Who cannot join
- Topical or systemic antifungal medications one month prior to enrollment in the study
- Presence of systemic disease, such as hepatic,renal, cardiac, autoimmune diseases, or malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Walaa Hemdan Abu Alhassan, Demonstrator contact
Egypt1 site
Faculty of Medicine , Sohag university
Sohag
Noha Shafik, 01067261504, nohasaber@med.sohag.edu.eg
Walaa Hemdan
About this study
Official title: Clinical, Dermoscopic, and Mycological Characteristics of Tinea Capitis in Children: A Cross-sectional Study
Tinea capitis is a common dermatophyte infection of the scalp in children aged 0-9 years .The prevalence of tinea capitis in Egypt is 0.4% and higher in public than private schools, Boys were more affected than girls according to children by 5:1 ratio , It is more prevalent in those who live in urban areas, large families, low socioeconomic level, crowded living conditions and immunocompromised people . Tinea capitis is caused by dermatophyte fungi Trichophyton and Microsporum genera. These fungi are classified as: anthropophilic, zoophilic, and geophilic according to the route of infection. These fungi invade the hair shaft in two routes: ectothrix and endothrix . T.tonsurans and T.violaceum are reported to be the most common cause of tinea capitis
Read the detailed description
Clinical types of tinea capitis include : scaly type (characterized by fine scaling and circular alopecia), black dot (characterized by non-inflammatory patches with broken-off, swollen hair stubs), tinea agminate (patchy alopecia with scattered pustules or low-grade folliculitis), kerion (painful, boggy, inflammatory masses with alopecia, often confused with bacterial abscess) and favus (scutula, mousy odor) . Tinea incognito (steroid modified tinea) refers to dermatophytosis that has lost their usual clinical appearance due to the use of steroids.
The main clinical feature of dermatophyte scalp infections is the appearance of scaling of the scalp skin, which is associated with a variable degree of inflammation and itching . In some cases, the infection closely resembles seborrheic dermatitis or dandruff of the scalp. A pathognomonic feature is hair loss; hair often breaks a few millimeters or more above the skin surface. Broken or infected hairs are also slightly swollen and have a dull appearance .
Trichoscopy is a non-invasive and very useful technique for the diagnosis and follow-up of hair and scalp disorders. The presence of certain trichoscopic features allows accurate identifying of tinea capitis. In tinea capitis, specific signs can be seen like comma hair, corkscrew hair, bar code-like hair and zigzag hair . In tinea incognito trichoscopic finding include erythema, scaling, bent hair, Morse code hair, and micropustules .
Mycological examination was first performed using Potassium Hydroxide(KOH) to confirm the diagnosis of tinea capitis where the patients with positive KOH were considered to have endothrix when observing arthroconidia inside the hair shaft and ectothrix when observing arthroconidia outside the hair shaft. The fungal culture also done to accurately recognize the organism through inoculation of samples on Sabouraud medium agar (SDA) with and without chloramphenicol(nonspecific medium) . And Dermasel medium agar act as specific medium.
The increase in antifungal resistance has recently been observed worldwide and resistant strains of the dermatophytes T. rubrum and T. indotineae have spread globally, causing outbreaks of extensive, difficult to treat infections , so we need rapid and reliable diagnostic tools that provide clues regarding the causative organisms.
- Conditions
- Fungal Infection by Site, Tinea Capitis
- Being tested
- Dermoscopic examination: the findings are divided into pathognomic and non-specific signs, Direct Microscopy (KOH) examination, Fungal culture:, Antifungal sensitivity:
- Keywords
- Tinea capitis, antifungal resistance, dermatophyte, KOH
- Medical subject headings
- Tinea Capitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermoscopic examination: the findings are divided into pathognomic and non-specific signsDiagnostic test
- Pathognomic signs: comma hairs, corkscrew hairs, Morse code like hairs and zig-zag hairs.
- Non-specific signs: black dots, broken hairs, perifollicular scaling and inter follicular erythema
Direct Microscopy (KOH) examinationDiagnostic test
- Suspected lesions will be swabbed with 70% ethyl alcohol then scalp scraping using the blunt edge of a sterile surgical blade
- Skin scales and crusts will be collected from the erythematous, peripheral, actively expanding edges of the lesions onto clean glass slides by scraping the inflamed lesions the scales will contain infected stumps of hair
- Hair will be removed with the root intact (hair cutting will be avoided)
- Specimen will be prepared by mounting the sample in (10-30%) of potassium hydroxide with 40% Dimethyle sulphoxide (DMSO) drops on the petri slide to soften the tissue, allowing a thin layer of cells to form.
Fungal culture:Diagnostic test
Specimen will be cultured on sabouraud's dextrose agar (SDA) at 25 -30 c for 2 to 4 weeks and another specimen will be cultured on a Dermasel agar base (Oxoid, UK), both supplemented with chloramphenicol and cycloheximide , staining the fungal colonies by Lactophenol cotton blue to help the examination of colonial morphology and microscopic examination of the macro-conidia allow the identification of the dermatophyte species and suitable treatment
Antifungal sensitivity:Diagnostic test
Antifungal susceptibility testing will be performed to determine the specific sensitivity profiles of the fungal isolates. Antifungal susceptibility testing will be performed using seven antifungal agents: Terbinafine, Itraconazole, Griseofulvin, Fluconazole, Ketoconazole, Vorioconole and Miconazole. Dermatophytes colonies will be probed from Dermasel agar cultures.
| Study group | Role | What they receive |
|---|---|---|
| patients with tinea capitis both male and female in childhood period | Not described Receives: Diagnostic Test: Dermoscopic examination: the findings are divided into pathognomic and non-specific signs; Diagnostic Test: Direct Microscopy (KOH) examination; Diagnostic Test: Fungal culture:; Diagnostic Test: Antifungal sensitivity: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants presenting with specific clinical patterns of tinea capitis
Clinical evaluation will be performed to identify and classify the presentation of tinea capitis lesions (e.g., scaly patches, black dots, kerion, favus).
Measured: At the time of initial clinical evaluation
Percentage of participants exhibiting specific dermoscopic features of tinea capitis
Dermoscopic examination using a handheld dermatoscope to identify characteristic signs including comma hairs, corkscrew hairs, broken hairs, and scaling.
Measured: At the time of initial dermoscopic evaluation
Prevalence of isolated fungal species among pediatric tinea capitis cases
Mycological evaluation including direct microscopic KOH preparation and fungal culture on agar media to isolate and identify the causative fungal pathogens.
Measured: At the time of initial sample collection and culture identification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal Infection by SiteStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Hemdan Aboelhasan, Sohag University
- Investigators
- Mohammed Abu El Hamd Ali, Study chair, Faculty of Medicine , Sohag universityDoaa Gaber Abdelbaset, Study chair, Faculty of Medicine , Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802600
- Sponsor's protocol ID
- Soh-Med-26-8-10MS
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Dermoscopic, and Mycological Characteristics of Tinea Capitis in Children: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07802600
- Acronym / sponsor ID
- Soh-Med-26-8-10MS
- Conditions
- Fungal Infection by Site, Tinea Capitis
- Keywords
- Tinea capitis, antifungal resistance, dermatophyte, KOH
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tinea capitis is a common dermatophyte infection of the scalp in children aged 0-9 years .The prevalence of tinea capitis in Egypt is 0.4% and higher in public than private schools, Boys were more affected than girls according to children by 5:1 ratio , It is more prevalent in those who live in urban areas, large families, low socioeconomic level, crowded living conditions and immunocompromised people . Tinea capitis is caused by dermatophyte fungi Trichophyton and Microsporum genera. These fungi are classified as: anthropophilic, zoophilic, and geophilic according to the route of infection. These fungi invade the hair shaft in two routes: ectothrix and endothrix . T.tonsurans and T.violaceum are reported to be the most common cause of tinea capitis
Detailed description
Clinical types of tinea capitis include : scaly type (characterized by fine scaling and circular alopecia), black dot (characterized by non-inflammatory patches with broken-off, swollen hair stubs), tinea agminate (patchy alopecia with scattered pustules or low-grade folliculitis), kerion (painful, boggy, inflammatory masses with alopecia, often confused with bacterial abscess) and favus (scutula, mousy odor) . Tinea incognito (steroid modified tinea) refers to dermatophytosis that has lost their usual clinical appearance due to the use of steroids.
The main clinical feature of dermatophyte scalp infections is the appearance of scaling of the scalp skin, which is associated with a variable degree of inflammation and itching . In some cases, the infection closely resembles seborrheic dermatitis or dandruff of the scalp. A pathognomonic feature is hair loss; hair often breaks a few millimeters or more above the skin surface. Broken or infected hairs are also slightly swollen and have a dull appearance .
Trichoscopy is a non-invasive and very useful technique for the diagnosis and follow-up of hair and scalp disorders. The presence of certain trichoscopic features allows accurate identifying of tinea capitis. In tinea capitis, specific signs can be seen like comma hair, corkscrew hair, bar code-like hair and zigzag hair . In tinea incognito trichoscopic finding include erythema, scaling, bent hair, Morse code hair, and micropustules .
Mycological examination was first performed using Potassium Hydroxide(KOH) to confirm the diagnosis of tinea capitis where the patients with positive KOH were considered to have endothrix when observing arthroconidia inside the hair shaft and ectothrix when observing arthroconidia outside the hair shaft. The fungal culture also done to accurately recognize the organism through inoculation of samples on Sabouraud medium agar (SDA) with and without chloramphenicol(nonspecific medium) . And Dermasel medium agar act as specific medium.
The increase in antifungal resistance has recently been observed worldwide and resistant strains of the dermatophytes T. rubrum and T. indotineae have spread globally, causing outbreaks of extensive, difficult to treat infections , so we need rapid and reliable diagnostic tools that provide clues regarding the causative organisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with tinea capitis both male and female in childhood period | – | Diagnostic Test: Dermoscopic examination: the findings are divided into pathognomic and non-specific signs, Diagnostic Test: Direct Microscopy (KOH) examination, Diagnostic Test: Fungal culture:, Diagnostic Test: Antifungal sensitivity: |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study will be conducted at the Dermatology Outpatient Clinic in Sohag University Hospitals. Study population: The study population will be all patients with tinea capitis both male and female in childhood period, Aged 1-18 years old
Key inclusion criteria (1 listed)
- Both male and female in childhood period (1-18 years) with tinea capitis
Key exclusion criteria (2 listed)
- Topical or systemic antifungal medications one month prior to enrollment in the study
- Presence of systemic disease, such as hepatic,renal, cardiac, autoimmune diseases, or malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermoscopic examination: the findings are divided into pathognomic and non-specific signs1. Pathognomic signs: comma hairs, corkscrew hairs, Morse code like hairs and zig-zag hairs. 2. Non-specific signs: black dots, broken hairs, perifollicular scaling and inter follicular erythema | Diagnostic test | patients with tinea capitis both male and female in childhood period |
| Direct Microscopy (KOH) examination1. Suspected lesions will be swabbed with 70% ethyl alcohol then scalp scraping using the blunt edge of a sterile surgical blade 2. Skin scales and crusts will be collected from the erythematous, peripheral, actively expanding edges of the lesions onto clean glass slides by scraping the inflamed lesions the scales will contain infected stumps of hair 3. Hair will be removed with the root intact (hair cutting will be avoided) 4. Specimen will be prepared by mounting the sample in (10-30%) of potassium hydroxide with 40% Dimethyle sulphoxide (DMSO) drops on the petri slide to soften the tissue, allowing a thin layer of cells to form. | Diagnostic test | patients with tinea capitis both male and female in childhood period |
| Fungal culture:Specimen will be cultured on sabouraud's dextrose agar (SDA) at 25 -30 c for 2 to 4 weeks and another specimen will be cultured on a Dermasel agar base (Oxoid, UK), both supplemented with chloramphenicol and cycloheximide , staining the fungal colonies by Lactophenol cotton blue to help the examination of colonial morphology and microscopic examination of the macro-conidia allow the identification of the dermatophyte species and suitable treatment | Diagnostic test | patients with tinea capitis both male and female in childhood period |
| Antifungal sensitivity:Antifungal susceptibility testing will be performed to determine the specific sensitivity profiles of the fungal isolates. Antifungal susceptibility testing will be performed using seven antifungal agents: Terbinafine, Itraconazole, Griseofulvin, Fluconazole, Ketoconazole, Vorioconole and Miconazole. Dermatophytes colonies will be probed from Dermasel agar cultures. | Diagnostic test | patients with tinea capitis both male and female in childhood period |
Primary outcome
Percentage of participants presenting with specific clinical patterns of tinea capitis
Time frame: At the time of initial clinical evaluation
Clinical evaluation will be performed to identify and classify the presentation of tinea capitis lesions (e.g., scaly patches, black dots, kerion, favus).
Percentage of participants exhibiting specific dermoscopic features of tinea capitis
Time frame: At the time of initial dermoscopic evaluation
Dermoscopic examination using a handheld dermatoscope to identify characteristic signs including comma hairs, corkscrew hairs, broken hairs, and scaling.
Prevalence of isolated fungal species among pediatric tinea capitis cases
Time frame: At the time of initial sample collection and culture identification
Mycological evaluation including direct microscopic KOH preparation and fungal culture on agar media to isolate and identify the causative fungal pathogens.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Walaa Hemdan Abu Alhassan, Demonstrator contact
Mohammed Abu El Hamd Ali study chair
Faculty of Medicine , Sohag university
Doaa Gaber Abdelbaset study chair
Faculty of Medicine , Sohag university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Infection by Site and Tinea Capitis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Shafik, Assistant professor (01067261504, nohasaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants presenting with specific clinical patterns of tinea capitis (time frame: At the time of initial clinical evaluation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.